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Clinical Investigations for Medical Devices

Dr Gillian McNab

Following the revision of the Medical Device Regulations (MDR) published in May 2017, there has been an introduction of strict rules for clinical investigations (trials) of medical devices and an alignment to the clinical trial regulation for investigational medicinal products.

This workshop will allow you to have a detailed look at which medical devices need a clinical investigation, how to apply for regulatory body approval, what a medical device trial entails and costs involved. As such, you will gain an understanding of the requirements the new MDR poses for clinical investigations of medical devices and how this will affect your company.